Lasermatic Surgilaser Model 5050
FDA 510(k) K870587 · Lasermatic OY
510(k) numberK870587
Submission
- Device name
- Lasermatic Surgilaser Model 5050
- Applicant
- Lasermatic OY
Finland, FI - Received
- February 10, 1987
- Decision date
- August 10, 1988
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- EWG – Laser, Ent Microsurgical Carbon-Dioxide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4500
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code EWG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K924652 | Benson CCA100EWG · Traditional | Benson Medical Instruments Co. | 04/09/1993SE |
| K880429 | Illumina 55 CO2 Laser SystemEWG · Traditional | Cooper Lasersonics, Inc. | 04/18/1988SE |
| K880428 | Illumina 25 CO2 Laser SystemEWG · Traditional | Cooper Lasersonics, Inc. | 04/18/1988SE |
| K880427 | Illumina 40 CO2 Laser SystemEWG · Traditional | Cooper Lasersonics, Inc. | 04/18/1988SE |
| K872710 | Model 20-B W/OB-10A/U Attach. for Ear, Nose/ThroatEWG · Traditional | Directed Energy, Inc. | 09/24/1987SE |
| K870840 | Model 20-C W/BR-20A/U Attach/Model HL-3.O AttachEWG · Traditional | Directed Energy, Inc. | 06/12/1987SE |
| K864975 | Laserscope Omniplus Photosurgical System for (ENT)EWG · Traditional | Laserscope | 02/25/1987SE |
| K862866 | Model 10-C W/LP-10A/U & OS-10A/U for Oral/Ent UseEWG · Traditional | Directed Energy, Inc. | 01/09/1987SE |
| K862865 | Model 10-C W/LP-10A/U & OB-10A/U for Oral/Ent UseEWG · Traditional | Directed Energy, Inc. | 01/09/1987SE |
| K862150 | Model 8-B with OS-1 Attachment (C02 Laser for ENT)EWG · Traditional | Directed Energy, Inc. | 09/04/1986SN |
More from Directed Energy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K903131 | Lasermatic Supercombo(Tm) Surgical Laser SystemGEX · Traditional | 02/19/1991SE |
| K901638 | Modified Combolaser 5050 & New Model 5050 Ver. 33GEX · Traditional | 06/27/1990SE |
| K895279 | Lasermatic Combolaser Model 5050GEX · Traditional | 11/08/1989SE |
| K893529 | Combolaser Model 5050GEX · Traditional | 06/08/1989SE |
| K871875 | Model 5050 Surgilaser for Ob-Gyn UseHHR · Traditional | 08/22/1988SE |
| K871934 | Model 5050 Surgilaser for Gastro-Intestinal UseLNK · Traditional | 03/25/1988SE |
| K871932 | Model 5050 Surgilaser for Urology UseLNK · Traditional | 03/25/1988SE |
| K871933 | Model 5050 Surgilaser for Neurosurgery UseGEX · Traditional | 01/22/1988SE |
| K871876 | Model 5050 Surgilaser for Pulmonary UseLLO · Traditional | 01/22/1988SE |
Questions and answers
When was Lasermatic Surgilaser Model 5050 cleared by the FDA?
Lasermatic Surgilaser Model 5050 (K870587) received a 510(k) decision of Substantially Equivalent for Some Indications on August 10, 1988, 547 days after the submission was received.
What is the product code of K870587?
The FDA product code is EWG – Laser, Ent Microsurgical Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 874.4500.